Clinical evaluation in healthy adults of a hepatitis B vaccine made by recombinant DNA
E. M. Scolnick, A. A. McLean, D. J. West, W. J. McAleer, W. J. Miller and E. B. Buynak
A vaccine formulated from hepatitis B surface antigen (HBsAg) produced by a
recombinant strain of the yeast Saccharomyces cerevisiae was administered
to two groups of human volunteers composed of 37 healthy, low-risk adults.
Each subject received a 10-micrograms dose of HBsAg at 0, 1, and 6 months.
By one month, 27% to 40% of the vaccinees had antibody to HBsAg, and by
three months 80% to 100% were antibody positive. Large boosts in titer
followed the third dose at six months. The antibody formed is predominantly
specific for the a determinant of HBsAg. There have been no serious
reactions attributable to the vaccine. The most frequent complaint has been
transient soreness at the injection site. As far as we know, this is the
first reported use in man of a vaccine prepared by recombinant DNA
technology.
